Description

3 clatms. (c1. 12e- 349) This invention relates to "a catheter, and,` more-"paliticularly, to` a catheter in which there is provided athin,

expansible section which is inflated or expanded byinjecting fluid suchas liquid or a gas through'a passageway extending longitudinally of the'cath'eter. i f f "Catheters are used for different medical purposes; but vmore often -in the human urinary bladder wherein they mayY be left in situ for considerable time, lextending into days. In the usual practice, the catheter'is introduced into'the bladder and a small amountof liquid ysuch as Alive cubic centimeters, more or less,I of sterile 'distilled water is injected through the passage into-the expansible section,` creating an enlargement or. bulb surrounding a portion of the catheter within the bladder and thus' serving -to prevent the catheter'fromworking out ofthe bladder.

The small tube through whichthe distilled water is into braidthe tubes 18 by' u'singfa' thirty-two'ca'rrieg ljected is clamped toprevent the escapeof therdistilled 4*When s uch a catheter -is introduced in to the human urinary bladder and the expansibleportion inated, it sometimes happens that due to individual 'hurnan'f'conf formations or other causes, the small passageway or'tube through which the expansible section is inflated becomeskinkcd or collapsed or'occluded. Further; thefpassage way may become blocked by `apartiele carriedjiin the distilled water stream. As Va result,the expans'ibl'esec;

tion cannot be deflatedv in thenormal- Way bymerelyre; moving the clamp from` the small tube through which the' distilled Water was first injected. When. this y'occiisga' serious medical problem arises,Y requiring :arlinvolved and painful procedure. Usually, it' is attempted to rupture or puncture the inated portionto4 enablethe distilled passages Y16 of the tubes 14'and 1'5.

Patented ,May 17,1969

2 1 plan view of the upper portion of the catheter structure showing the anking tubes united at one end. In the illustration given, A vdesignates a catheter hav'- ing a pointed end portion10 and a transverse uid recess 11; 12 designates a tluidki passage extending longitudinally of the catheter and communicatingfwith the transverse wall passage 11.` Near the transverse recess 11 and spaced rearwardly therefrom, is a tubular'inflatable sectionlB which normally lies flat, as indicated in dotted lines 'in Fig.v 2, but which,` under fluid pressure, expands to the form shown in full lines in Fig. 2. f f

Flanking the central luidfpassage4 12" are two-huid'- conveying `tubes 14 and l15 which lead forwardly, and

'communicate withy the interior of lthe eigpansible section braider with 32 strands ofv vsize 70 denier nylonyar'n, which'produces vagtrrri, close, AAbraided tube with 'ho vopen spaces between ,the strands. Thef braided'fnylon tubes are preferably dipped into 'latexrubber for their 'entire length-one `ormore times until the desired deposit 'of latex rubber, -or the like, has been attained. -Thetuhas 14 and 15in their completed formmay thenj` ein'jcorporated with the central tube member to'vffo'rm e l bs cemented in place so as to communicate with the outlet vrnfposite 'structure illustrated, 'and h tube 13 mayv While the catheter may lbeformed in any suitable manner, the following procedure has lbeen found very satisfactory. Themain tube, with thecentral passage 12, is first formedby using a round, solid steel rod having a tapered point at thedistal end vand having ja water to be released and thereby`l collapsethe-inflated section.

- It is of paramountinlportancethat suchfla catheter provide the ultimate in safety .and providedependable meansffor lsterilizing lthe inatable section, v as well as means for inating and deating the same,` Y

An object lof, the Apresent invention is to provide means for effectively overcomingthe above .described'difculties and to provide a catheter in which a section canbe effectively `sterilized while removing the sterlizing medium and'while also providing means for'the removal .of a

blocking particle -or providing for the .removal of th'e finflating lluid in spite of kinkedl or collapsed portionsV of the passages, etc. Yet another object is to provide improved 'means for theformingof tluid tubes leading to the .inatable section, whereby the ldanger of vcollapsing is largely eliminated. Other specific objects fand'fad vantages will appearas the specification proceeds.

lTheinvention is shown, in an illustrative embpdip; ment, by the accompanyingy drawing, in vvhicli-l-I Figure l is a broken planview of a catheter embodying my invention; Fig 2, an enlarged broken sectional view; Fig. 3, an -enlarged sectional view, the sectionfbeing taken as indicated at line 3 3 of Fig.'2; Fi'g. 4,- abroke'n, part-sectional view of the? tube`communicatingwiththe tapered and cylindrical shape at the proximal end, cofre# sponding substantially with the shape of the passage vshown in Figs. l and 2. This steelrod form is then dipped kin'rubber to`formy a central portion of the tube The braided tubes 18 arerthen placed upon the rod forms which have the shapeA of the passages illustrated in Fig'. l. The forms covered yby the braided tubes 18 are'then dipped in lat'exto ,form the covering of latex indicated by Vthe `numeral 19 to form thextub'ef14, s'illustrated -best in-Fig.`4. The two braidedftubs; withftheirjrubber covering 19 and while still carried upon the rod fornts; are-brought together with the initial rod form adtli rubbercovering'thereof so that the entirestruc'ture is similar to Ithat shown in' Fig. 41, the var'ion's'steel forms occupying the space shown bythe passages in dotted lines in 1i" ig.,l.H The assembled forms are then dipped together in rubber to'unite the'tub'es 14 and 15 withthe central tu e. 'f "f The stainless steel forms are then ret-n ovedfv and `the eyes "onopenings 16- are formed as' inc,li t :ated` in Fig. 2 to provide -communication between the 'central passages` 20 of the `braided tubes with the interior of the inflatable section 134:" The inatable section 'i or tube" 1,3 -'sV neil: secured ,-in position so asl to' cover the recesses "16"and the section is cemented at its ends intlie p osition expansible section of the catheter; and Fig.4 5, la. 'broken' in Fig. 2. I then prefer to dip thev assembled structure into latex rubber throughout its entire length one -of'two timesmuntv a smooth overall surface"and"symmti`c-al' contour isk provided.- Then the central stel-'rbdp f o'i is 'removed from. the passage 12x andatransverse or opening 11 is cut in the distal end of the catheter so as to complete the structure.

While I have described .a method in which steel rod .means :or processes for .the .forming of the completed catheter .structurepmay be used. v y .With the structure. as shown, .Iprov-ide a .substantially continuous passage from vone of the yinlets .such as b to the other outlet 14h, or vice versa, `so that a .sterilizing liquid `can be forced continuously in a unidirectional ow through the tube member 13 so as to steril'ize the tube member and .to force any Ablocking particle within the passage therefrom. lWith this structure, it is .also possible 'to alternate the how so .as to successfully disf lodge any blocking material or particleand to yunkink or open any collapsed portion Vof the tubing. I .have further Vfound that by braidingthe tubing as .indicated .at .18 or by forming the .tubes in .a knitted .or woven manner and thenv sealing the tubing with latex, etc., lan effective tube is formed which does netcollapse in the operation .of the structure, thus permitting .fluid to be vforced through the vtubes .continuously or alternately or reciproeated, .so that there .is no necessity for puncturing `the bulb 13 or of providing a bulb `which is unsterile or contains a body of sterilizing medium.

In lthe operation .of the catheter, the catheter is pre- Y liminarily treated with a sterilizing iuid, `such as liquid.

After the sterilizingoperation, the iluid may be entirely removed by passing a gaseous medium continuously through .the member 13, the iluid being introduced through one tube such as 14a and discharged through the other tube such as 15a. The sterilized catheter .may then 4*be inserted and :the bulb 13 .inated to maintain .the catheter in position. To maintain the lpressurezuid for its iniation purpose, yclamps may be placed upon the .tubes 14a and 15a. When it is desired to .remove the catheter, the clamps may be removed and if there is any obstruction in the passages, tluid may be forced iirst through Ione tube 1S and then through the other tube 14 alternately or in a uni-directional ow so as to dislodgeany blocking particle and so as to overcome Vany kinked or collapsed portion. Further, any one of the passages 14a and 15a which is not kinked or obstructed provides a passage for the escape or removal of the. pressure fluid. As a result of the `two-passage tiguous to the latex covering the central form. A similar length of latex tube is cemented to the opposite side of the latex-covered central form. I then position the wire form, funnel end and holding device, and dip the composite structure in latex to form the tube with the parallel central and anking passages. This method is used also with the braided nylon-reinforced latex tubing; however, the nylon tube is made by first braiding the tube over a length of straight Wire and then dipping it into latex, drying, and then removing the wire. While the foregoing method gis preferred, it will be understood .that rthe structure herein may be formed in any suitable manner.

In the forming of the catheter, stainless ,steel forms in the nature of rods having one or two grooves in them may be employed, and tubes formed in the grooves so as to provide a catheter having an overall more rounded form-.in cross section. The catheter may be formed in a variety .of cross-sectional shapes, with the flanking `tubesor passagesv indented within the central catheter body to provide a round shape or in portions extending laterally of the .circular central body to produce an oblong shape., or in a great variety of cross-sectional shapes. While :the braided tube or reinforcing tube shown has been described :in vconnection with'tlie preferred embodiment employing two ilanking tubes or passages, it will be `understood that the braided tube may be formed effectively with a single flanking passage in the usual type of catheter, and lin .such a structure, a safer catheteris obtained in that the plastic threads limit the expansion of the tubes even under high pressures and thus provide a Asafe structure in which expansion will be coniined to the inflatable tube portion of the structure.

In vthe specific structure shown in Fig. 5, the tube por` tions 14a and`15a are united into one terminal tube portion 21. Confusion in the operation ofthe catheter is thus avoided .and a safer product is obtained. To circulate a sterile solution through the catheter, one would insert .a 'long Luer needle of appropriate size into either of the tubes. The needle could also be used to inflate the catheter by pinching or closing the tube into which the needle does not extend. Also, if desired, the tip of the syringe can be inserted directly into the large -or structure, there is certainty for the removal of the catheter without requiring rupture of the inflated section 13, and further the inflated section 13 is kept free .of the sterilizing medium by .the use of the two passages.

As already stated, after use of the catheter, the interior passages of the Y.tubes 14 and 15 and the iniiatable section 13 may be, eiectively sterilized by passing `a sterilizing liquid through one ofv the passages,` thence through the section 13, and linally out -of the `other passage. Further, for effective sterilization, the stream of liquid `may be reversed. Finally, vto .make certain ythat all .of the liquid is removed, a gaseous sterilizing medium maybe forced through one passage to section 13 and thence out .the other passage. It will be understood that any effective sterilizing uid may be used in the foregoing steps.V

Robben as .used herein, is intendedV to cover ,natural or synthetic rubber, including natural latex, neoprene latex, etc. In a. preferred operation, the main form consisting of stainless steel, etc., ris dipped one or more in the latex or rubber until the desired deposit has been obtained. I then make a latex tube bydipping a straight lengthV of stainless steel wire in lateroneV or more times until the desired .deposit Vot latex has been obtained. After. drying vthe `latex deposit, I remove-the wireA and havev a length of latex tubing which I out to the desired length, cementing it in parallel andcouf terminal part 21 for inating the catheter. In forming the united tube structure shown in Fig. 5, I employ Wires for Vforming the tubes 14a and 15a and a large terminal into Vwhich the wires extend with a push-'fit After dipping the structure to'forrn the rubber tubes, I first remove the large metal part within the tube 21 and then pull the lwires out separately, since these wires'protrude Vinto the tube 21 after removing the large metal part.

It will be understood, however, that any suitable means for forming the united tube structure may be employed.

While, in the foregoing specification, I have set forth a specific structure andl mode of procedure in V'considerable detail for the purpose of illustrating the invention, itwll be understood that such details of structure and procedure may be varied widely vby those skilled in the art without departing from the spirit of my invention;

I claim: l Y .f '1. A catheter, comprising along, flexible, resilient body provided at one distal end with a Wall recess spaced from said 'end Iand havingV a longitudinaluid passage communicatingwith said recess, an inflatable tube secured to saidfbody near .said recess, and a vbraided yarn tube impregnated with rubber and embedded in said body paralleling said longitudinal fluid passage, said braided tube communicating with said flexible tube and maintainimpregnated with rubber and embedded'in said body to provide longitudinal passages flanking `said fluid passage, said longitudinal passages communicating with said inflatable tube to provide a continuous passage: from theinlet of one anking passagel through said inflatable tube and to the outlet of said other flanking passage. y

3. A catheter, comprising a long, flexible, resilient body provided at one distal end with a wall recess spaced from said distal end and having a longitudinalruid passage communicating with said recess, 'an inflatable tube secured to said body near said recess, a pair of lungi! t,

of said body at the end opposite said distal end, and a terminal tube uniting said pair of tubes to provide a single terminal passage.